For people ages 18-100
Major Inclusion Criteria:
- Patients ≥18 years of age at the time of signing informed consent
- Documented RRMM for which no standard therapy options are anticipated to result in a durable remission. Relapse defined as progressive disease after initial response (minimal response [MR] or better) to previous treatment, more than 60 days after cessation of last treatment. Refractory disease defined as <25% reduction in M protein or progression of disease during treatment or within 60 days after cessation of treatment.
- Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
- Measurable disease defined as at least one of the following:
- Serum M-protein ≥0.5 g/dL
- Urine M-protein ≥200 mg/24 hours
- Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
- Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤1.
Major Exclusion Criteria:
- Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)
- Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.
- Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study
- Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded
- Last anticancer treatment within 2 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)